Abstract
Background
Pose SM is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported.
Methods
Subjects with classes I–II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months.
Results
From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred.
Conclusions
In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters.
Study registration: clinicaltrials.gov identifier # NCT01843231
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Acknowledgments
We would like to thank Stephanie Amlung, PhD, RN, USGI Medical, San Clemente, CA, USA for database integration and management and T. W. McGlennon, M3 LLC, Maiden Rock, Wisconsin, USA, for statistical analysis. We also thank Marcus Radauer, MSc and Jonas Philipp, MD (Austria) and Rochelle Nelissen (the Netherlands) for their assistance in this study.
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Ethical Approval
As stated in the Methods, all procedures involving human participants were performed in this study in accordance with the ethical standards of the institutional and national research committees and with the 1964 Helsinki declaration and its later amendments.
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Informed consent was obtained from all individual participants included in the study.
Disclosures
Manuscript development was financially supported by USGI Medical, Inc., San Clemente, CA, USA. Dr. Miller (Salzburg, Austria), Dr. Espinós (Barcelona, Spain), Dr. Turró (Barcelona, Spain), and Dr. Greve (Heerlen, the Netherlands) received investigator consulting fees from USGI Medical. J. N. Buchwald, Chief Scientific Research Writer and Director, Medwrite LLC, WI, USA received fees from USGI Medical for statistical analysis and manuscript development.
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Miller, K., Turró, R., Greve, J.W. et al. MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy. OBES SURG 27, 310–322 (2017). https://doi.org/10.1007/s11695-016-2295-9
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DOI: https://doi.org/10.1007/s11695-016-2295-9